Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer
Recruiting now · Phase 3
Conditions studied: Oligometastatic Squamous Cell Carcinoma of the Head and Neck
In brief
This is a randomized open-label multicentre phase III superiority study of the effect of adding SABR to the standard of care treatment pembrolizumab on progression free survival in patients with oligometastases of a squamous cell carcinoma of the head and neck (SCCHN), histological confirmation of the primary disease at first diagnosis, and PD-L1 CPS ≥1. After eligibility check and signing informed consent, all patients will be prospectively enrolled in a 1:1 ratio between current standard of care treatment (pembrolizumab, Arm 1) vs. SABR + standard of care treatment (Arm 2) to oligometastases. Any radical treatment to the synchronous primary/ recurrent primary tumor and/or involved cervical nodes (surgery or radiotherapy), as decided by the local tumor board/ treating physicians, should be completed prior to enrolment.Surgical removal of metastases is allowed for diagnostic purposes or for brain metastases, as long as these metastases count toward the total number of 5 and at least one metastasis is left for treatment with SABR. Such surgical procedures should be performed prior to enrolment.
Key facts
- Study ID
- NCT05815927
- Run by
- European Organisation for Research and Treatment of Cancer - EORTC
- People needed
- 200
- Starts
- 2025-05-23
- Expected to finish
- 2030-03-30
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (enrolling)
- Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus (previous GZA) — Wilrijk, Belgium (enrolling)
- Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi — Florence, Italy (enrolling)
- Istituto Clinico Humanitas — Milan, Italy (enrolling)
- IRCCS - Fondazione Istituto Nazionale dei Tumori — Milan, Italy (enrolling)
- Azienda ospedaliero Univ Policlinico Umberto I — Rome, Italy (enrolling)
- Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia — Barcelona, Spain (enrolling)
- ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) — Barcelona, Spain (enrolling)
- Hospital Universitario de Gran Canaria Doctor Negrin — Las Palmas de Gran Canaria, Spain (enrolling)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (enrolling)
- Hospital Universitario San Carlos — Madrid, Spain (enrolling)
- Inselspital - Inselspital — Bern, Switzerland (enrolling)
- Luzerner Kantonsspital — Lucerne, Switzerland (enrolling)
- UniversitaetsSpital Zurich — Zurich, Switzerland (enrolling)
- AZ Groeninge Kortrijk - Campus Kennedylaan — Kortrijk, Belgium (enrolling)
- CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur — Namur, Belgium (enrolling)
- VITAZ St Niklaas - VITAZ- Oncology — Sint-Niklaas, Belgium (enrolling)
- CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont — Haine-Saint-Paul, Belgium
- Institut Català d'Oncologia - Hospital Duran i Reynals — Badalona, Spain
- Hospital Universitario De Cruces — Barakaldo, Spain
- Hospital Universitario Virgen De La Victoria — Málaga, Spain
- Kantonsspital Aarau — Aarau, Switzerland
- IRCCS--Ospedale Bellaria-Bologna — Bologna, Italy
- Azienda Ospedaliera Santa Croce E Carle — Cuneo, Italy
- Oncology Institute of Southern Switzerland (IOSI) - Oncology Institute of Southern Switzerland - Ospedale San Giovanni — Bellinzona, Switzerland
Full record on ClinicalTrials.gov
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